Material Safety Data Sheet Copyright, 2004, 3M Company. All rights reserved. Copying and/or downloading of this information for the purpose of properly utilizing 3M products is allowed provided that: (1) the information is copied in full with no changes unless prior written agreement is obtained from 3M, and (2) neither the copy nor the original is resold or otherwise distributed with the intention of earning a profit thereon. SECTION 1: PRODUCT AND COMPANY IDENTIFICATION PRODUCT NAME: 3M(TM) Attest(TM) Biological Indicators 1262 (steam), 1262P, 1261 (flash), 1261P MANUFACTURER: 3M DIVISION: Medical Division ADDRESS: 3M Center St. Paul, MN 55144-1000 EMERGENCY PHONE: 1-800-364-3577 or (651) 737-6501 (24 hours) Issue Date: Supercedes Date: 04/22/2004 Document Group: 11-2863-6 Product Use: Specific Use: To indicate conditions for sterilization. SECTION 2: INGREDIENTS Ingredient C.A.S. No. % by Wt Plastic vial and cap Unknown 40-55 Growth media containing carbohydrates, amino acids, bromcresol purple Unknown 30-40 Glass ampule Unknown 15-30 Spore strip with Geobacillus stearothermophilus (previously Bacillus stearothermophilus) Unknown < 1 SECTION 3: HAZARDS IDENTIFICATION 3.1 EMERGENCY OVERVIEW Specific Physical Form: Glass ampule with test strip and media, enclosed in a covered plastic vial. Odor, Color, Grade: Glass ampule with test strip and media, enclosed in a covered plastic vial. General Physical Form: Liquid Immediate health, physical, and environmental hazards: 3.2 POTENTIAL HEALTH EFFECTS Eye Contact: Page 1 of 6
No health effects are expected.accidental breakage of the vial could result in glass shards entering the eye, causing irritation or lacerations to the ocular tissues. Skin Contact: No health effects are expected.irritation or lacerations could occur from accidental breakage of the vial resulting in glass shards abrading or entering the skin. Inhalation: No health effects are expected. Ingestion: No health effects are expected. Geobacillus stearothermophilus is a non-pathogenic organism. Growth media in container is not considered toxic. SECTION 4: FIRST AID MEASURES 4.1 FIRST AID PROCEDURES The following first aid recommendations are based on an assumption that appropriate personal and industrial hygiene practices are followed. Eye Contact: Skin Contact: Inhalation: No need for first aid is anticipated. No need for first aid is anticipated. No need for first aid is anticipated. If Swallowed: No need for first aid is anticipated. SECTION 5: FIRE FIGHTING MEASURES 5.1 FLAMMABLE PROPERTIES Autoignition temperature Flash Point Flammable Limits - LEL Flammable Limits - UEL 5.2 EXTINGUISHING MEDIA Ordinary combustible material. Use fire extinguishers with class A extinguishing agents (e.g., water, foam). 5.3 PROTECTION OF FIRE FIGHTERS Special Fire Fighting Procedures: Wear full protective equipment (Bunker Gear) and a self-contained breathing apparatus (SCBA). Unusual Fire and Explosion Hazards: Not applicable. Page 2 of 6
Note: See STABILITY AND REACTIVITY (SECTION 10) for hazardous combustion and thermal decomposition information. SECTION 6: ACCIDENTAL RELEASE MEASURES Accidental Release Measures: Collect as much of the spilled material as possible. Clean up residue with detergent and water. Collect the resulting residue containing solution. Place in a closed container approved for transportation by appropriate authorities. Seal the container. Dispose of collected material as soon as possible. In the event of a release of this material, the user should determine if the release qualifies as reportable according to local, state, and federal regulations. SECTION 7: HANDLING AND STORAGE 7.1 HANDLING For industrial or professional use only. 7.2 STORAGE Store away from areas where product may come into contact with food or pharmaceuticals. Store between 15-30 degree C. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 ENGINEERING CONTROLS Not applicable. 8.2 PERSONAL PROTECTIVE EQUIPMENT (PPE) 8.2.1 Eye/Face Protection Avoid eye contact. 3M recommends the use of safety glasses whem removing biological indicators from the sterilizer and when crushing biological indicators. 8.2.2 Skin Protection Gloves are not required. Warning: Crushing or excessive handling of the biological indicators before cooling may cause the glass ampule to burst which may result in personal injury from flying debris. Use crusher to activate unit. 3M recommends the use of gloves when removing biological indicators from the sterilizer. 8.2.3 Respiratory Protection Not applicable. 8.2.4 Prevention of Swallowing Do not ingest. 8.3 EXPOSURE GUIDELINES None Established Page 3 of 6
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Specific Physical Form: Glass ampule with test strip and media, enclosed in a covered plastic vial. Odor, Color, Grade: Glass ampule with test strip and media, enclosed in a covered plastic vial. General Physical Form: Liquid Autoignition temperature Flash Point Flammable Limits - LEL Flammable Limits - UEL Boiling point Approximately 100 ºC [Details: (applies to media)] Density 1 g/ml Vapor Density Vapor Pressure Specific Gravity Approximately 1 [Ref Std: WATER=1] ph Approximately 7.5 [Details: (applies to media)] Melting point Solubility in Water Negligible Evaporation rate Volatile Organic Compounds Percent volatile Approximately 0 % VOC Less H2O & Exempt Solvents Viscosity SECTION 10: STABILITY AND REACTIVITY Stability: Stable. Materials and Conditions to Avoid: None known Hazardous Polymerization: Hazardous polymerization will not occur. Hazardous Decomposition or By-Products Substance Condition Not applicable. Not Specified SECTION 11: TOXICOLOGICAL INFORMATION Please contact the address listed on the first page of the MSDS for Toxicological Information on this material and/or its components. Page 4 of 6
SECTION 12: ECOLOGICAL INFORMATION ECOTOXICOLOGICAL INFORMATION Not determined. CHEMICAL FATE INFORMATION Not determined. SECTION 13: DISPOSAL CONSIDERATIONS Waste Disposal Method: facility's policy. Autoclave at 120C for at least 15 minutes and dispose with microbiological waste according to your EPA Hazardous Waste Number (RCRA): Not regulated Since regulations vary, consult applicable regulations or authorities before disposal. SECTION 14:TRANSPORT INFORMATION ID Number(s): 70-2005-0348-3, 70-2005-0349-1, 70-2005-0440-8, 70-2005-0441-6, 70-2005-3864-6, 70-2010-0555-3 Please contact the emergency numbers listed on the first page of the MSDS for Transportation Information for this material. SECTION 15: REGULATORY INFORMATION US FEDERAL REGULATIONS 311/312 Hazard Categories: Fire Hazard - No Pressure Hazard - No Reactivity Hazard - No Immediate Hazard - No Delayed Hazard - No STATE REGULATIONS CHEMICAL INVENTORIES This material contains one or more substances not listed on the TSCA Inventory. Commercial use of this material is regulated by the Page 5 of 6
FDA. INTERNATIONAL REGULATIONS This MSDS has been prepared to meet the U.S. OSHA Hazard Communication Standard, 29 CFR 1910.1200. SECTION 16: OTHER INFORMATION NFPA Hazard Classification Health: 0 Flammability: 0 Reactivity: 0 Special Hazards: None National Fire Protection Association (NFPA) hazard ratings are designed for use by emergency response personnel to address the hazards that are presented by short-term, acute exposure to a material under conditions of fire, spill, or similar emergencies. Hazard ratings are primarily based on the inherent physical and toxic properties of the material but also include the toxic properties of combustion or decomposition products that are known to be generated in significant quantities. Revision Changes: Section 1: Product name was modified. Section 1: Division name was modified. Section 2: Ingredient table was modified. Section 14: ID Number(s) was modified. Page Heading: Product name was modified. DISCLAIMER: The information in this Material Safety Data Sheet (MSDS) is believed to be correct as of the date issued. 3M MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR COURSE OF PERFORMANCE OR USAGE OF TRADE. User is responsible for determining whether the 3M product is fit for a particular purpose and suitable for user's method of use or application. Given the variety of factors that can affect the use and application of a 3M product, some of which are uniquely within the user's knowledge and control, it is essential that the user evaluate the 3M product to determine whether it is fit for a particular purpose and suitable for user's method of use or application. 3M provides information in electronic form as a service to its customers. Due to the remote possibility that electronic transfer may have resulted in errors, omissions or alterations in this information, 3M makes no representations as to its completeness or accuracy. In addition, information obtained from a database may not be as current as the information in the MSDS available directly from 3M. 3M MSDSs are available at www.3m.com Page 6 of 6